Investigate a Interaction of Candesartan and Atorvastatin in Healthy Male Sugjects
Phase 1
- Conditions
- Healthy Male Subjects
- Registration Number
- NCT02609711
- Lead Sponsor
- Ahn-Gook Pharmaceuticals Co.,Ltd
- Brief Summary
primary object : Evaluate pharmacokinetic drug-drug interaction of Candesartan and Atorvastatin
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 90
Inclusion Criteria
- Adult healthy males 20 to 45 years at screening.
- BMI 18-29 kg/m2
Exclusion Criteria
- History of cardiovascular, respiratory, hepatic, renal, neuropsychiatric, endocrine, hematologic disease
- Hypersensitivity reactions to drugs or significant hypersensitivity reactions in the history of Candesartan and Atorvastatin
- Hypotension (DBP ≤ 100 mmHg or SBP ≤ 95mmHg) and hypertension (SBP ≥ 150 mmHg or DBP ≥ 95 mmHg)
- Gastrointestinal disease affected the absorption of medications
- Genetic disease of Galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
- AST or ALT > 2 x normal range
- Total bilirubin > 2.0 mg/dl
- CK > 2 x normal range
- eGFR < 60 mL/min/1.73m2
- Subject who have drunken habitually (alcohol more than 21 units/week, 1 unit = 10 g = 12.5 mL of pure alcohol) or who are unable to quit drinking during this study
- Subject who have smoke habitually more than 10 cigarettes/day or who are unable to quit smoking during this study
- Subject who treated with any investigational drugs within 90 days before the administration of investigational drug
- Previously donate whole blood within 60 days or component blood within 30 days or transfusion within 30 days
- Subject who treated with any drug within 30 days can affect absorption, distribution, metabolism, excretion of candesartan or atorvastatin
- Subject who treated with any Rx only drug or herbal drug within 14 days and any OTC within 7 days
- History of drug abuse
- Genetic neuromuscular disorder or family history of neuromuscular disorder
- Unusual diet affected the absorption, distribution, metabolism, excretion of medications
- Subjects deemed ineligible by investigator based on other reasons
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method AUClast (Atorvastatin) 0, 0.25, 0.5, 0.75, 1, 1.333, 1.667, 2, 3, 4, 6, 8, 12, 24, 48 hours Cmax (Candesartan cilexetil) 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours Cmax (Atorvastatin) 0, 0.25, 0.5, 0.75, 1, 1.333, 1.667, 2, 3, 4, 6, 8, 12, 24, 48 hours AUClast (Candesartan cilexetil) 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Inha Univ. Hospital
🇰🇷Incheon, Korea, Republic of